Transurethral Catheter Safety Valve (TUCSV) (80050)

FDA 510(k) K260919 · Class Medical , Ltd.

Substantially Equivalent

510(k) numberK260919

Submission

Device name
Transurethral Catheter Safety Valve (TUCSV) (80050)
Applicant
Class Medical , Ltd.
Co Limerick, IE
Received
March 19, 2026
Decision date
August 5, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNY – Accessories, Catheter, G-U
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KNY

510(k)DeviceApplicantDecision
K182144Bi-Flex EvoKNY · Special Promepla Sam09/07/2018SE
K162356Vesair Cystoscopic SheathKNY · Special Solace Therapeutics03/02/2017SE
K140441Bi-Flex Ureteral Access SheathKNY · Traditional Promepla Sam06/17/2014SE
K140562Wijay Ez-Void External Catheter ValveKNY · Traditional Leomed, LLC06/16/2014SE
K141252Guardian Urethral SheathKNY · Special Solace Therapeutics06/09/2014SE
K131803Guardian Urethral SheathKNY · Special Solace Therapeutics08/20/2013SE
K123170Vari-Pass Variable Length Access SheathKNY · Special Olympus Surgical Technologies America02/04/2013SE
K120160Rocamed Rocaus PlatinumKNY · Traditional Promepla Sam05/14/2012SE
K112209Prefilled Catheter Inflation SyringeKNY · Special Avail Medical Products, Inc.09/08/2011SE
K090121Pre-Filled Catheter Inflation SyringeKNY · Special Avail Medical Products, Inc.04/15/2009SE

Questions and answers

When was Transurethral Catheter Safety Valve (TUCSV) (80050) cleared by the FDA?

Transurethral Catheter Safety Valve (TUCSV) (80050) (K260919) received a 510(k) decision of Substantially Equivalent on August 5, 2026, 139 days after the submission was received.

What is the product code of K260919?

The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.